ULTRA-VIOLET BUN REAGENT KIT— 510(k) K851513

Name: FDA 510(k) clearance K851513
Creator: U.S. Food and Drug Administration
Published: 1985-05-20

Substantially Equivalent

Bio-Analytics Laboratories, Inc.

FDA 510(k) clearance K851513 for ULTRA-VIOLET BUN REAGENT KIT, Substantially Equivalent on 1985-05-20. Applicant: Bio-Analytics Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Analytics Laboratories, Inc.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1985-04-15
Decision date: 1985-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm City, FL, US

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